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Consideration of Critical Material Attributes in Hypromellose Based Hydrophilic Matrices Comprising Drugs of Various Solubility Hua Deng, Lawrence Martin, Brad Prusak, Shahrzad Missaghi, Thomas P. Farrell Poster Reprint and Ali Rajabi-Siahboomi CRS 2013 Abstract Summary Two case studies were conducted to evaluate the material attributes of hypromellose (METHOCEL™ K4M premium cellulose ethers) and Starch 1500® partially pregelatinized maize starch on the performance of extended release (ER) matrices. Variations in the properties of hypromellose K4M had minimal effect on theophylline release profiles, but changes in hydroxypropyl substitution levels (% HP) and particle size of the polymer impacted the drug release from hydrochlorothiazide (HCTZ) matrix tablets. Variations in Starch 1500 properties had no significant effect on drug release regardless of drug solubility. In both case studies, coarse Starch 1500 particles resulted in slightly lower tablet strength. Introduction Hypromellose is the most commonly used polymer in ER hydrophilic matrix formulations. The effect of hypromellose (METHOCEL K15M PRCR, K100LV PR CR) on the performance of hydrophilic matrix tablets was previously investigated and the critical material attributes (CMA) of METHOCEL were discussed.1-3 Use of Starch 1500 in hypromellose matrices has been shown to enhance the robustness of drug release from hydrophilic ER tablets.2,4 The objective of this study was to examine the influence of material attributes on the characteristics of hydrophilic ER matrices comprising METHOCEL K4M and Starch 1500 as the matrix former. Two case studies were conducted using theophylline (water solubility 8.3 mg/mL) or HCTZ (water solubility ~0.7 mg/mL) as model drugs. Experimental Methods Quali